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Investigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home Care

This study has been withdrawn prior to enrollment.
(No resources available at the clinic)
Sponsor:
Information provided by:
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01164982
First received: July 16, 2010
Last updated: December 14, 2010
Last verified: December 2010
History of Changes
  Purpose

The primary objective is to evaluate the handling of Mepitel® One when used in acute wounds in home care.

Secondary objective is to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events.


Condition Intervention
Acute Wounds
 Device: Mepitel One

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: An Open Non-controlled Proof of Concept Investigation Evaluating the Handling of a Soft Silicone Wound Contact Layer, Mepitel® One Used in Acute Wounds in Home Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • to evaluate the handling of Mepitel® One when used in acute wounds in home care. [ Time Frame: once a week for 3 weeks or until healing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events. [ Time Frame: once a week for 3 weeks or until healing ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2010
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Mepitel One
    Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier
Detailed Description:

The investigation is designed as an open, non-controlled, proof of concept investigation. Subjects with acute wounds at one centre will be included. Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier. All dressing changes will be done according to clinical routine and registered in a dressing log. Cover dressing will be used when needed according to clinical routine.

A total of 10 subjects will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and have signed and dated the written informed consent.

The subjects will be consecutively allocated to a subject code.

At baseline, subject characteristics will be registered together with subject status of health, wound history and wound status, wound characteristics and current treatment of the wound.

The following variables will be measured as follows:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute wounds/burns
  2. Male or female, 18 years and above, both in- and outpatients.
  3. Signed Informed Consent Form

Exclusion Criteria:

  1. Wound size above 21x24.5 cm
  2. Subject not expected to follow the investigation procedures
  3. Subjects previously included in this investigation
  4. Subjects included in other ongoing clinical investigation at present or during the past 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164982

Locations
Germany
Chir-Praxis
Hamburg, Hamm, Germany, 59065
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
Principal Investigator: Hans J Höning, Dr Chir-Praxis, Hamburg
  More Information

No publications provided

Responsible Party: Jenny Thorell, Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01164982     History of Changes
Other Study ID Numbers: MPTO 02
Study First Received: July 16, 2010
Last Updated: December 14, 2010
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on May 23, 2013